BR112016021034A8 - pharmaceutical composition, use thereof and kit - Google Patents
pharmaceutical composition, use thereof and kitInfo
- Publication number
- BR112016021034A8 BR112016021034A8 BR112016021034A BR112016021034A BR112016021034A8 BR 112016021034 A8 BR112016021034 A8 BR 112016021034A8 BR 112016021034 A BR112016021034 A BR 112016021034A BR 112016021034 A BR112016021034 A BR 112016021034A BR 112016021034 A8 BR112016021034 A8 BR 112016021034A8
- Authority
- BR
- Brazil
- Prior art keywords
- disease
- kit
- pharmaceutical composition
- carbidopa
- antioxidant
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 abstract 2
- 239000003963 antioxidant agent Substances 0.000 abstract 2
- 230000003078 antioxidant effect Effects 0.000 abstract 2
- 235000006708 antioxidants Nutrition 0.000 abstract 2
- 229960004205 carbidopa Drugs 0.000 abstract 2
- TZFNLOMSOLWIDK-JTQLQIEISA-N carbidopa (anhydrous) Chemical compound NN[C@@](C(O)=O)(C)CC1=CC=C(O)C(O)=C1 TZFNLOMSOLWIDK-JTQLQIEISA-N 0.000 abstract 2
- 201000010099 disease Diseases 0.000 abstract 2
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 239000004475 Arginine Substances 0.000 abstract 1
- WTDRDQBEARUVNC-LURJTMIESA-N L-DOPA Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-LURJTMIESA-N 0.000 abstract 1
- WTDRDQBEARUVNC-UHFFFAOYSA-N L-Dopa Natural products OC(=O)C(N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-UHFFFAOYSA-N 0.000 abstract 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 1
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 abstract 1
- 208000018737 Parkinson disease Diseases 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- 229960005070 ascorbic acid Drugs 0.000 abstract 1
- 235000010323 ascorbic acid Nutrition 0.000 abstract 1
- 239000011668 ascorbic acid Substances 0.000 abstract 1
- 230000009286 beneficial effect Effects 0.000 abstract 1
- 230000015556 catabolic process Effects 0.000 abstract 1
- 238000006731 degradation reaction Methods 0.000 abstract 1
- 208000035475 disorder Diseases 0.000 abstract 1
- 229960003638 dopamine Drugs 0.000 abstract 1
- 210000005064 dopaminergic neuron Anatomy 0.000 abstract 1
- 229960004502 levodopa Drugs 0.000 abstract 1
- 229960003194 meglumine Drugs 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
Abstract
composição farmacêutica, uso de tal composição, método para tratar uma doença e kit a presente invenção provê composições farmacêuticas altamente estáveis baseadas em carbidopa compreendendo uma combinação de antioxidante consistindo em ácido ascórbico e pelo menos um antioxidante adicional em que dita combinação inibe fortemente a degradação de carbidopa. estas composições podem adicionalmente compreender levodopa e/ou um ou ambos arginina e meglumina, e são benéficos no tratamento de uma doença, distúrbio ou condição associada com perda de dopamina ou neurônios dopaminérgicos, por exemplo, doença de parkinson.pharmaceutical composition, use of such composition, method to treat a disease and kit the present invention provides highly stable pharmaceutical compositions based on carbidopa comprising an antioxidant combination consisting of ascorbic acid and at least one additional antioxidant wherein said combination strongly inhibits the degradation of carbidopa. these compositions may further comprise levodopa and/or one or both of arginine and meglumine, and are beneficial in the treatment of a disease, disorder or condition associated with loss of dopamine or dopaminergic neurons, e.g. Parkinson's disease.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461952477P | 2014-03-13 | 2014-03-13 | |
US201461990967P | 2014-05-09 | 2014-05-09 | |
PCT/IL2015/050258 WO2015136538A1 (en) | 2014-03-13 | 2015-03-12 | Dopa decarboxylase inhibitor compositions |
Publications (2)
Publication Number | Publication Date |
---|---|
BR112016021034A2 BR112016021034A2 (en) | 2017-08-15 |
BR112016021034A8 true BR112016021034A8 (en) | 2021-06-29 |
Family
ID=53488380
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112016021034A BR112016021034A8 (en) | 2014-03-13 | 2015-03-12 | pharmaceutical composition, use thereof and kit |
Country Status (19)
Country | Link |
---|---|
US (4) | US10022320B2 (en) |
EP (3) | EP3777833B1 (en) |
JP (2) | JP6591995B2 (en) |
CN (1) | CN106413754B (en) |
AU (1) | AU2015228369B2 (en) |
BR (1) | BR112016021034A8 (en) |
CA (1) | CA2942244C (en) |
DK (2) | DK3116475T3 (en) |
ES (2) | ES2967693T3 (en) |
FI (1) | FI3777833T3 (en) |
HR (2) | HRP20231716T1 (en) |
HU (2) | HUE052642T2 (en) |
IL (1) | IL247668B (en) |
MX (1) | MX2016011837A (en) |
PL (2) | PL3777833T3 (en) |
PT (2) | PT3116475T (en) |
RS (1) | RS65060B1 (en) |
RU (1) | RU2684105C2 (en) |
WO (1) | WO2015136538A1 (en) |
Families Citing this family (13)
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PT3192500T (en) | 2009-05-19 | 2021-01-05 | Neuroderm Ltd | Compositions for continuous administration of dopa decarboxylase inhibitors |
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US10258585B2 (en) | 2014-03-13 | 2019-04-16 | Neuroderm, Ltd. | DOPA decarboxylase inhibitor compositions |
ES2967693T3 (en) | 2014-03-13 | 2024-05-03 | Neuroderm Ltd | Dopa decarboxylase inhibitor compositions |
CA2997791A1 (en) | 2015-09-30 | 2017-04-06 | Duke University | Ascorbate formulations and methods of use as contrast agents |
WO2018154447A1 (en) * | 2017-02-21 | 2018-08-30 | Neuroderm Ltd | Dopa decarboxylase inhibitor compositions |
SG11202104499RA (en) | 2018-11-15 | 2021-05-28 | Abbvie Inc | Pharmaceutical formulations for subcutaneous administration |
WO2020178810A1 (en) * | 2019-03-04 | 2020-09-10 | Neuroderm, Ltd. | Pharmaceutical compositions comprising levodopa amide derivatives and uses thereof |
CN111701024B (en) * | 2020-05-26 | 2022-05-24 | 上海京新生物医药有限公司 | Levodopa preparation and preparation method and application thereof |
US11331293B1 (en) | 2020-11-17 | 2022-05-17 | Neuroderm, Ltd. | Method for treatment of Parkinson's disease |
US11844754B2 (en) | 2020-11-17 | 2023-12-19 | Neuroderm, Ltd. | Methods for treatment of Parkinson's disease |
US11213502B1 (en) | 2020-11-17 | 2022-01-04 | Neuroderm, Ltd. | Method for treatment of parkinson's disease |
CN113396897B (en) * | 2021-07-26 | 2022-06-07 | 苏州华测生物技术有限公司 | Method for stabilizing carbidopa/levodopa in biological matrix |
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ES2967693T3 (en) | 2014-03-13 | 2024-05-03 | Neuroderm Ltd | Dopa decarboxylase inhibitor compositions |
US10258585B2 (en) | 2014-03-13 | 2019-04-16 | Neuroderm, Ltd. | DOPA decarboxylase inhibitor compositions |
PT3209302T (en) | 2014-10-21 | 2019-07-19 | Abbvie Inc | Carbidopa and l-dopa prodrugs and their use to treat parkinson's disease |
CN108495617A (en) | 2015-11-24 | 2018-09-04 | 纽罗德姆有限公司 | Including the pharmaceutical composition of levodopa amide and its purposes |
WO2018154447A1 (en) | 2017-02-21 | 2018-08-30 | Neuroderm Ltd | Dopa decarboxylase inhibitor compositions |
WO2019038638A1 (en) | 2017-08-21 | 2019-02-28 | Neuroderm Ltd | Process for preparing purified levodopa amide |
WO2019038639A1 (en) | 2017-08-21 | 2019-02-28 | Neuroderm Ltd | Crystalline levodopa amide free base and methods of making and using same |
AR112472A1 (en) | 2017-08-21 | 2019-10-30 | Neuroderm Ltd | FORM OF LEVODOPA AMIDA CRYSTALLINE SALTS AND METHODS FOR PREPARING AND USING THEM |
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